labs@atheron:~/industries/pharma$ validate --gxp --part11 --audit-trail

Pharma software

Regulated science, with the audit trail built in.

In life sciences, your system is only as good as the record it leaves. We build trial apps, safety tools and supply ledgers with audit trails, signatures and validation documents designed in from the start. Nothing is added in a rush before an inspection.

Start a project See the example projects

// what you are up against

The problems we hear most.

Paper in the trial

Participants fill in paper diaries late or all at once before a visit, and site staff transcribe them into the EDC with errors at each step.

Safety reports by the hundred

Adverse event reports arrive as emails, forms and call notes, and trained staff read every one to find the drug, the event and the deadline.

SOPs nobody can find

The answer is in a controlled document somewhere, but which version, which section and whether it is still effective takes longer to find than the work itself.

Validation slows every change

Each change to a GxP system needs evidence it still works as intended, so teams avoid changing systems that badly need it.

// example projects

Systems we could build for you.

Each one is hypothetical, labelled as such, and priced live from our rate card. Open any of them in the estimator and make it yours.

Example projectWeb appMobile app

Trial participant diary app

Hypothetical. Not a client, not a result.

// The problem

A sponsor running a multi-site trial collects symptom diaries on paper, filled in late or all at once, and site staff transcribe them into the EDC.

// What we would build

An iOS and Android diary app with reminders at the right time of day, a site portal for coordinators, and a data export to the EDC, with the audit trail and electronic signatures 21 CFR Part 11 and ICH GCP expect.

// What is in it

Diary entries timestamped on the device, with late entries clearly marked
Reminders on the participant's own schedule, in their language
A site portal where coordinators see compliance and follow up
Audit trail of every entry and change, with reason for change
Data export to the sponsor's EDC on an agreed schedule
Validation package: requirements, test scripts and traceability matrix

// Stack

React Native
Next.js
PostgreSQL
EDC export interface
AWS (Canada region)

// estimate

Build: ≈ US$167,000 to US$255,000, delivered within 37 weeksCAD 237,200 to 362,900
Hosting: ≈ US$492 a monthCAD 700 a month
Support: ≈ US$5,010 a monthCAD 7,135 a month

Prices in your currency are estimates from today's Bank of Canada rate. All invoicing is in CAD or USD.

Timeline by milestone

Discovery: 2.9 to 3.4 weeks
Design approved: 6.4 to 11.4 weeks
Core features: 1.9 to 2.9 weeks
Full build: 1.4 to 1.9 weeks
First build on devices: 3.4 to 5.9 weeks
Testing and fixes: 0.4 to 0.9 weeks
Store submission: 0.4 to 0.9 weeks
Validation package delivered: 0.9 to 1.4 weeks
Controls built and evidenced: 0.4 to 0.9 weeks
Readiness review: 0.4 to 8.4 weeks
Launch: 0.9 to 1.4 weeks

Outside our hands, and added to the calendar

App store review: 1 week
Vendor test environment access: 1 to 4 weeks
Business associate agreements with your vendors (HIPAA): 2 to 6 weeks
Booking a penetration tester and their report: 2 to 4 weeks

How it is paid

Deposit 20%: CAD 47,440 to 72,580
Discovery 5.9%: CAD 13,994.80 to 21,411.10
Design approved 5.9%: CAD 13,994.80 to 21,411.10
Core features 4.8%: CAD 11,385.60 to 17,419.20
Full build 3.2%: CAD 7,590.40 to 11,612.80
First build on devices 12.8%: CAD 30,361.60 to 46,451.20
Testing and fixes 1.6%: CAD 3,795.20 to 5,806.40
Store submission 4.2%: CAD 9,962.40 to 15,241.80
Validation package delivered 12.7%: CAD 30,124.40 to 46,088.30
Controls built and evidenced 6.3%: CAD 14,943.60 to 22,862.70
Readiness review 6.3%: CAD 14,943.60 to 22,862.70
Launch 6.3%: CAD 14,943.60 to 22,862.70
Holdback, 30 days after launch (10%): CAD 23,720 to 36,290

Start from this example

Example projectWeb appAICustom LLM

Safety case intake model

Hypothetical. Not a client, not a result.

// The problem

A pharmacovigilance team reads every incoming adverse event report by hand to find the product, the event, the patient details and the reporting clock.

// What we would build

A custom model, further trained on medical and safety literature and then on the team's own de-identified cases, that reads each report and proposes the case fields and MedDRA terms, which a safety specialist then checks, running on a GPU server inside the company.

// What is in it

Reports from email, web forms and call notes read into case fields
Suggested MedDRA terms with the passage they came from
Seriousness and reporting deadline flagged for a specialist to check
A model trained further on safety language, then on your cases
Scored against a held-out set of your cases before every release

// Stack

Open-weight base model, further trained
PyTorch
Python
Next.js
Lenovo GPU server on site

// estimate

Build: ≈ US$269,000 to US$407,000, delivered within 55 weeksCAD 382,400 to 579,600
Hosting: ≈ US$176 a monthCAD 250 a month
Support: ≈ US$2,500 a monthCAD 3,565 a month
Hardware: ≈ US$47,800 to US$197,000CAD 68,000 to 280,800

Prices in your currency are estimates from today's Bank of Canada rate. All invoicing is in CAD or USD.

AI route: Custom LLM
Model running cost: ≈ US$176 a monthCAD 250 a month

Timeline by milestone

Discovery: 2.9 to 3.4 weeks
Data and evaluation plan: 0.4 weeks
Design approved: 2.9 to 4.9 weeks
Core features: 2.4 to 3.9 weeks
Full build: 1.4 to 2.9 weeks
Training: 16.4 to 28.4 weeks
Testing and fixes: 0.4 weeks
Evaluation and red-teaming: 3.9 to 4.4 weeks
Validation package delivered: 3.9 to 4.4 weeks
Launch: 0.9 to 1.4 weeks
Production: 0.9 to 1.4 weeks

Outside our hands, and added to the calendar

Hardware delivery, after it is ordered: 2 to 6 weeks
Vendor test environment access: 1 to 4 weeks

How it is paid

Deposit 20%: CAD 74,980 to 114,420
Discovery 0.7%: CAD 2,624.30 to 4,004.70
Data and evaluation plan 6.8%: CAD 25,493.20 to 38,902.80
Design approved 0.7%: CAD 2,624.30 to 4,004.70
Core features 2.2%: CAD 8,247.80 to 12,586.20
Full build 1.4%: CAD 5,248.60 to 8,009.40
Training 20.4%: CAD 76,479.60 to 116,708.40
Testing and fixes 0.7%: CAD 2,624.30 to 4,004.70
Evaluation and red-teaming 13.6%: CAD 50,986.40 to 77,805.60
Validation package delivered 15.5%: CAD 58,109.50 to 88,675.50
Launch 0.7%: CAD 2,624.30 to 4,004.70
Production 7.3%: CAD 27,367.70 to 41,763.30
Holdback, 30 days after launch (10%): CAD 37,490 to 57,210
GPU time for training and testing, at cost: CAD 7,500. Billed up front, at cost, outside the milestones
GPU server for AI, for the model: CAD 68,000 to 280,800. Billed up front, at cost, outside the milestones

Start from this example

Example projectWeb appAIOpen-source model

SOP and documents assistant

Hypothetical. Not a client, not a result.

// The problem

Quality and manufacturing staff search a document system for the effective version of an SOP, and the section they need is buried in a long PDF.

// What we would build

An assistant that answers from effective SOPs only, cites the document, version and section, and opens a deviation form when asked, on an open-source model in the company's own cloud account so controlled documents stay private.

// What is in it

Effective SOPs, work instructions and forms indexed from your document system
Superseded versions excluded automatically
Every answer cites the document, version and section
A tool to start a deviation or change request with the context filled in
Evaluation set of real questions, run before every change

// Stack

Llama or Mistral (open-source)
vLLM
PostgreSQL with pgvector
Next.js
AWS GPU

// estimate

Build: ≈ US$130,000 to US$199,000, delivered within 24 weeksCAD 185,000 to 282,900
Hosting: ≈ US$6,710 a monthCAD 9,550 a month
Support: ≈ US$2,500 a monthCAD 3,565 a month

Prices in your currency are estimates from today's Bank of Canada rate. All invoicing is in CAD or USD.

AI route: Open-source model
Model running cost: ≈ US$6,530 a monthCAD 9,300 a month

Timeline by milestone

Discovery: 2.9 to 3.4 weeks
Specification and evaluation plan: 0.4 weeks
Design approved: 2.4 to 3.9 weeks
Core features: 1.4 to 2.4 weeks
Full build: 0.9 to 1.4 weeks
Working pilot: 4.4 to 7.4 weeks
Testing and fixes: 0.4 to 0.9 weeks
Validation package delivered: 0.9 to 1.9 weeks
Launch: 0.9 to 1.4 weeks
Production: 0.9 to 1.4 weeks

Outside our hands, and added to the calendar

Vendor test environment access: 1 to 4 weeks

How it is paid

Deposit 20%: CAD 36,940 to 56,520
Discovery 1.4%: CAD 2,585.80 to 3,956.40
Specification and evaluation plan 8.2%: CAD 15,145.40 to 23,173.20
Design approved 1.4%: CAD 2,585.80 to 3,956.40
Core features 4.4%: CAD 8,126.80 to 12,434.40
Full build 2.9%: CAD 5,356.30 to 8,195.40
Working pilot 24.7%: CAD 45,620.90 to 69,802.20
Testing and fixes 1.4%: CAD 2,585.80 to 3,956.40
Validation package delivered 15.5%: CAD 28,628.50 to 43,803.00
Launch 1.4%: CAD 2,585.80 to 3,956.40
Production 8.7%: CAD 16,068.90 to 24,586.20
Holdback, 30 days after launch (10%): CAD 18,470 to 28,260
GPU time for training and testing, at cost: CAD 300. Billed up front, at cost, outside the milestones

Start from this example

Example projectWeb appMobile appBlockchain

Trial supply custody ledger

Hypothetical. Not a client, not a result.

// The problem

Trial supplies move between the sponsor, a depot and dozens of sites, and the record of who held each kit, and at what temperature, is spread across spreadsheets and courier emails.

// What we would build

A shared chain of custody on a private permissioned ledger the sponsor, depot and CRO each run a node of, with an Android app for scanning kits at handover and a portal for temperature data and excursions.

// What is in it

Kit handovers scanned on an Android device at the depot and the site
Each handover and temperature reading recorded on a private chain
Excursions flagged at once, with the affected kits quarantined in the system
A full custody history for any kit, for the sponsor and inspectors
Interfaces to the IRT and the depot's inventory system

// Stack

Next.js
React Native (Android)
Hyperledger Besu (private, permissioned)
PostgreSQL
AWS

// estimate

Build: ≈ US$181,000 to US$276,000, delivered within 35 weeksCAD 257,100 to 393,200
Hosting: ≈ US$492 a monthCAD 700 a month
Support: ≈ US$2,500 a monthCAD 3,565 a month

Prices in your currency are estimates from today's Bank of Canada rate. All invoicing is in CAD or USD.

Timeline by milestone

Discovery: 2.9 to 3.4 weeks
Architecture: 0.4 weeks
Design approved: 4.4 to 7.9 weeks
Core features: 1.9 to 2.9 weeks
Full build: 0.9 to 1.9 weeks
First build on devices: 2.4 to 3.9 weeks
Devnet: 2.9 to 5.4 weeks
Testing and fixes: 0.4 weeks
Store submission: 0.4 weeks
Testnet: 2.9 to 3.4 weeks
Validation package delivered: 2.9 to 3.4 weeks
Launch: 0.9 to 1.4 weeks
Mainnet: 0.9 to 1.4 weeks

Outside our hands, and added to the calendar

App store review: 1 week
Vendor test environment access: 1 to 4 weeks

How it is paid

Deposit 20%: CAD 51,420 to 78,640
Discovery 3.8%: CAD 9,769.80 to 14,941.60
Architecture 3.5%: CAD 8,998.50 to 13,762.00
Design approved 3.8%: CAD 9,769.80 to 14,941.60
Core features 3.9%: CAD 10,026.90 to 15,334.80
Full build 2.6%: CAD 6,684.60 to 10,223.20
First build on devices 7.7%: CAD 19,796.70 to 30,276.40
Devnet 10.5%: CAD 26,995.50 to 41,286.00
Testing and fixes 1.3%: CAD 3,342.30 to 5,111.60
Store submission 2.5%: CAD 6,427.50 to 9,830.00
Testnet 7%: CAD 17,997 to 27,524
Validation package delivered 15.5%: CAD 39,850.50 to 60,946.00
Launch 3.8%: CAD 9,769.80 to 14,941.60
Mainnet 4.1%: CAD 10,541.10 to 16,121.20
Holdback, 30 days after launch (10%): CAD 25,710 to 39,320

Start from this example

Example projectWeb appAPI

LIMS, QMS and ERP joined

Hypothetical. Not a client, not a result.

// The problem

A contract manufacturer's lab results, deviations and batch records live in separate systems, and quality staff copy results between them before each batch can be released.

// What we would build

An integration that passes lab results from the LIMS to the batch record, opens a deviation in the QMS when a result is out of specification, and updates batch status in the ERP, with every transfer logged and validation documents written alongside.

// What is in it

Lab results passed to the batch record
Deviations opened when a result is out of specification
Batch status kept in step in the ERP
Every transfer logged, with validation documents

// Stack

Node.js
PostgreSQL
REST
OpenAPI
AWS Canada

// estimate

Build: ≈ US$112,000 to US$172,000, delivered within 28 weeksCAD 160,100 to 244,900
Hosting: ≈ US$176 a monthCAD 250 a month
Support: ≈ US$2,500 a monthCAD 3,565 a month

Prices in your currency are estimates from today's Bank of Canada rate. All invoicing is in CAD or USD.

Timeline by milestone

Discovery: 2.9 to 3.4 weeks
Design approved: 2.4 to 3.4 weeks
API contract agreed: 1.4 to 1.9 weeks
Core features: 1.4 to 2.4 weeks
Full build: 0.9 to 1.9 weeks
Core resources built: 2.9 to 5.4 weeks
Security, gateway and connections: 1.9 to 3.9 weeks
Testing and fixes: 0.4 weeks
Docs, SDKs and load tests: 1.4 to 1.9 weeks
Validation package delivered: 1.4 to 1.9 weeks
Launch: 0.9 to 1.4 weeks
Launch and first callers: 0.9 to 1.4 weeks

Outside our hands, and added to the calendar

Vendor test environment access: 1 to 4 weeks

How it is paid

Deposit 20%: CAD 32,020 to 48,980
Discovery 1.6%: CAD 2,561.60 to 3,918.40
Design approved 1.6%: CAD 2,561.60 to 3,918.40
API contract agreed 4.9%: CAD 7,844.90 to 12,000.10
Core features 5%: CAD 8,005 to 12,245
Full build 3.3%: CAD 5,283.30 to 8,081.70
Core resources built 14.7%: CAD 23,534.70 to 36,000.30
Security, gateway and connections 9.8%: CAD 15,689.80 to 24,000.20
Testing and fixes 1.6%: CAD 2,561.60 to 3,918.40
Docs, SDKs and load tests 4.9%: CAD 7,844.90 to 12,000.10
Validation package delivered 15.5%: CAD 24,815.50 to 37,959.50
Launch 1.6%: CAD 2,561.60 to 3,918.40
Launch and first callers 5.5%: CAD 8,805.50 to 13,469.50
Holdback, 30 days after launch (10%): CAD 16,010 to 24,490

Start from this example

Example projectWeb app

Trial operations dashboard

Hypothetical. Not a client, not a result.

// The problem

A sponsor's study team tracks enrolment, site activation and data query backlogs from weekly CRO reports in different formats, so problems at a site surface weeks late.

// What we would build

A dashboard that loads enrolment, site and data management figures from your study systems and partners on a schedule, showing enrolment against plan, open queries by site and age, and sites that need attention, with no participant identities in it.

// What is in it

Enrolment, site and query data loaded on a schedule
Enrolment against plan by site and country
Open data queries by site and age
Aggregate figures only, with no participant identities

// Stack

PostgreSQL
dbt
Apache Superset
Python
AWS Canada

// estimate

Build: ≈ US$70,700 to US$108,000, delivered within 17 weeksCAD 100,700 to 154,000
Hosting: ≈ US$492 a monthCAD 700 a month
Support: ≈ US$1,000 a monthCAD 1,425 a month

Prices in your currency are estimates from today's Bank of Canada rate. All invoicing is in CAD or USD.

Timeline by milestone

Discovery: 2.9 to 3.4 weeks
Design approved: 2.4 to 3.9 weeks
Core features: 2.4 to 3.9 weeks
Full build: 1.4 to 2.4 weeks
Testing and fixes: 0.4 to 0.9 weeks
Validation package delivered: 0.9 to 1.4 weeks
Launch: 0.9 to 1.4 weeks

Outside our hands, and added to the calendar

Vendor test environment access: 1 to 4 weeks

How it is paid

Deposit 20%: CAD 20,140 to 30,800
Discovery 6%: CAD 6,042 to 9,240
Design approved 6%: CAD 6,042 to 9,240
Core features 18.1%: CAD 18,226.70 to 27,874.00
Full build 12%: CAD 12,084 to 18,480
Testing and fixes 6%: CAD 6,042 to 9,240
Validation package delivered 15.5%: CAD 15,608.50 to 23,870.00
Launch 6.4%: CAD 6,444.80 to 9,856.00
Holdback, 30 days after launch (10%): CAD 10,070 to 15,400

Start from this example

// by service

Go deeper on one kind of work.

Pages for the services we have the most to say about in this industry.

~/apps

Clinical trial apps

Participant diary apps and site portals for clinical trials, with audit trails, electronic signatures and a validation package, built to work with the sponsor's EDC.

~/ai

AI for drug safety

Custom models for adverse event intake and open-source assistants over effective SOPs, run inside your own environment and measured on your own cases before use.

~/chains

Trial supply ledger

A chain of custody for clinical trial kits on a private permissioned ledger shared by sponsor, depot and CRO, with handover scanning and temperature excursions recorded as they happen.

~/compliance

Pharma compliance

GxP software built for validation: audit trails, controlled electronic records and signatures under 21 CFR Part 11 practices, HIPAA-ready handling of participant data, and validation documentation.

// questions

What buyers in this industry ask us.

Do you work under GxP?

We build to GMP, GCP and 21 CFR Part 11 expectations with your quality team, and deliver the documents they need. Your organisation remains responsible for validation and release; we support it.

Can our data stay in Canada or in our own data centre?

Yes. Apps can be hosted in a Canadian region, and models can run on servers you own.

How do payments work?

A deposit to start, then payments at agreed milestones, with 10% held until 30 days after launch. The deposit is a smaller share on larger projects.

Who owns the code, models and validation files?

You do, once the work is paid for, including models trained on your data.

// other industries

Nearby industries.

~/healthcare

Healthcare

Patient portals and apps, clinical note assistants, referral intake models and shared credential ledgers.

See the examples

~/supply-chain

Supply chain

Inbound control towers, multi-tier sourcing ledgers with supplier portals, supplier risk agents and sustainability data portals.

See the examples

~/manufacturing

Manufacturing

MES dashboards, technician apps, vision on the line, supplier portals and maintenance agents.

See the examples

All industries

// where we work

Find your market.

We work from Kelowna with clients across Canada, the United States and further afield. Each market page covers working hours, hosting, the privacy law that applies, and prices in your currency.

Every market

// next

Not quite your project?

Tell us what you have in mind. We will come back to you with a range and the questions that would narrow it. Or book a call and talk it through.

Start a project Book a call